Heron Therapeutics Announces Publication of Results from Phase 3 EPOCH 1 Study of HTX-011 in Patients Undergoing Bunionectomy
HTX-011 is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam in a 33:1 ratio. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control.
In the EPOCH 1 study, all primary and key secondary endpoints were achieved. HTX-011 provided superior and sustained pain reduction compared to placebo and bupivacaine solution through the critical 72-hour postoperative window, when pain is often most severe. Significant reductions in pain occurred both early (in the first 8 through 24 hours) and were sustained from 24 through 72 hours. In addition to reductions in average pain intensity scores, HTX-011 significantly reduced the proportion of patients experiencing severe pain through 72 hours compared to placebo and bupivacaine solution. Significant reductions in pain were consistent with the significant decrease in total opioid consumption and the significant increase in opioid-free patients receiving HTX-011, both through 72 hours and as compared to placebo and bupivacaine solution. Most patients that required no opioids in the first 72 hours after surgery (82%) continued to be opioid-free through 28 days. HTX-011 was well tolerated, with a safety profile comparable to placebo and bupivacaine solution.
"This publication demonstrates that HTX-011 can significantly reduce postoperative pain, including severe pain, for 72 hours post-surgery and reduce the need for opioids compared to bupivacaine solution," said
The RAPM article can be found here.
About the EPOCH 1 Study
EPOCH 1 was a randomized, placebo- and active-controlled, double-blind, Phase 3 clinical study evaluating the efficacy and safety of locally administered HTX-011 at 60 mg/1.8 mg bupivacaine/meloxicam compared to placebo and the standard dose of bupivacaine solution (50 mg) for postoperative pain control following bunionectomy surgery in 412 patients. All primary and key secondary endpoints were achieved:
- There was a 27% reduction in pain intensity as measured by the Area Under the Curve (AUC) 0-72 when comparing HTX-011 to placebo (p<0.0001).
- There was an 18% reduction in pain intensity as measured by AUC 0-72 when comparing HTX-011 to the current standard-of-care, bupivacaine solution (p=0.0002).
- Over 72 hours post-surgery, patients receiving HTX-011 consumed 37% less opioids than patients receiving placebo (p<0.0001) and 25% less opioids than patients receiving bupivacaine solution (p=0.0022).
- 29% of patients receiving HTX-011 required no opioid medication for 72 hours post-surgery compared to only 2% receiving placebo (p<0.0001) and 11% receiving bupivacaine solution (p=0.0001). These results parallel the significantly reduced incidence of severe pain in patients receiving HTX-011 compared to both placebo (36% reduction; p<0.0001) and bupivacaine solution (29% reduction; p<0.0001).
- Among the HTX-011-treated patients who were opioid-free through 72 hours post-surgery, more than 90% remained opioid free through day 10 and 82% remained opioid free through day 28.
- HTX-011 was well tolerated, with a safety profile comparable to placebo and bupivacaine solution.
About HTX-011 for Postoperative Pain
HTX-011, which utilizes Heron's proprietary Biochronomer® drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine solution in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the U.S. Food and Drug Administration (
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